Cleared Special

IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER

K022603 · Diagnostic Products Corp. · Toxicology
Aug 2002
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K022603 is an FDA 510(k) clearance for the IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on August 21, 2002, 15 days after receiving the submission on August 6, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K022603 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2002
Decision Date August 21, 2002
Days to Decision 15 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

Similar Devices — CEW Radioimmunoassay, Parathyroid Hormone

All 85
Elecsys PTH , Elecsys PTH STAT
K231927 · Roche Diagnostics · Mar 2024
Access Intact PTH
K232791 · Beckman Coulter, Inc. · Mar 2024
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K221197 · Ortho-Clinical Diagnostics · Sep 2023
Lumipulse G whole PTH
K190702 · Fujirebio Diagnostics,Inc. · Aug 2019
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658 · Siemens Healthcare Diagnostics, Inc. · May 2017
IDS-iSYS Intact PTHN
K161158 · Immunodiagnostic Systems , Ltd. · Jan 2017